Laser Acupuncture for Chronic Migraine
ConditionChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaichung Veterans General Hospital
About this trial
A single-blind randomized controlled trial was conducted from October 2024 to May 2025. Chronic migraine patients were randomly assigned in a 1:1 ratio to receive either Laser acupuncture or sham treatment. The co-primary outcomes were changes in monthly migraine days (MMD) and acute headache medications usage days per month from baseline, and Hospital Anxiety and Depression Scale (HADS), and Beck's Depression Inventory(BDI) evaluation. Evaluations were taken at baseline and each follow-up point.
After \>6 months follow up as washing out time, the sham group received complementary laser acupuncture treatment and follow up for another 3 months, compared the Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged above 20 years old and had CM managed pharmacologically, including preventive and/or acute migraine medications, and in addition, those who had refused preventive agent despite recommendation of the neurologist;
patients who had unsatisfactory effect of current pharmacological treatments, defined as they self-reported
patients who had a minimum of one-year history of migraine with or without aura.
Disqualifiers
patients who had received another LA therapy or traditional acupuncture at baseline
migraine onset after the age of 50
cognitive or psychological impairment interfering with the participant's ability to receive LA protocol and describe symptoms
patients with missing data at baseline or during the follow-up period.
Trial design
Design model
Crossover
Treatments tested in this trial
Laser Acupuncture
DeviceLaser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)
Sham
DeviceSham treatment with no laser output, stimulate the same acupoints as laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) After \> 6 months followed up, the sham group received truely Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3), and followed up for another 3 months.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: laser acupunctureExperimental treatment 1 intervention
Group B: Sham treatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
monthly migraine days
change in monthly migraine days (MMD) from baseline and each follow-up time point
Time frame
12 weeks, 24 weeks, 36 weeks2
acute headache medications usage days
change in acute headache medications usage days per month from baseline and each follow-up time point
Time frame
12 weeks, 24 weeks, 36 weeksSecondary outcomes
1
30% reduction in migraine days
≥ 30% reduction in migraine days between baseline and each follow-up time point
Time frame
12 weeks, 24 weeks, 36 weeks2
headache duration
changes in the headache duration between baseline and each follow-up time point
Time frame
12 weeks, 24 weeks, 36 weeks3
headache severity
changes in the headache severity (based on NRS) between baseline and each follow-up time point
Time frame
12 weeks, 24 weeks, 36 weeks4
the MIDAS score
changes in the MIDAS score between baseline and each follow-up time point
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov